NCT07459738 HLX-43 Hormone receptor positive HER2 negative breast cancer Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07459738 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 27 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07459738 is a hot trial to watch
Hormone receptor positive HER2 negative breast cancer is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07459738 is notable because it evaluates HLX-43 in a Phase 2 design sponsored by Shanghai Henlius Biotech, Inc.. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07459738 |
| Official title | A Phase II Study to Evaluate the Efficacy and Safety of HLX43 in Patients With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer |
| Phase / status | Phase 2 / Not yet recruiting |
| Intervention | HLX-43 |
| Sponsor | Shanghai Henlius Biotech, Inc. |
| Geography | Not reported in the indexed record |
| Enrollment | 60 |
| Primary endpoint | ORR |
| Endpoint time frame | Up to 24WEEK |
| Primary completion / readout proxy | 2026-12-30 |
Protocol design and endpoint interpretation
This is a Phase II Study of HLX43 in Hormone Receptor Positive，HER-2 negative Locally Advanced or Metastatic Breast Cancer Patients with Disease Progression on Standard of Care. Eligible subjects will be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first)
Allocation is Randomized, masking is None (Open Label), and the intervention model is Parallel Assignment. Planned enrollment of 60 participants across Not reported in the indexed record shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- ORR (Up to 24WEEK) — Objective response rate (ORR) assessed by IRRC (Independent Radiology Review Committee) per RECIST 1.1
- PFS (Up to 5 years) — Progression-Free Survival (PFS) assessed by IRRC (Independent Radiology Review Committee) per RECIST 1.1
Readout outlook and evidence gap
The current protocol points to 2026-12-30 as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Asset and sponsor context
Drug & Asset MCP profile: HLX-43 is indexed as No normalized modality returned, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status No normalized global status returned.
Company & Deal Intelligence MCP profile: Shanghai Henlius Biotech, Inc. is resolved to a normalized organization record in Shanghai Shi, China. The organization workflow adds identity, location, portfolio and partnering context where available.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
NCT07459738 provides a focused lens on Hormone receptor positive HER2 negative breast cancer development. Its value will be determined by whether HLX-43 can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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